Talc side effects: what 420 FDA adverse event reports show

Talc · Steritalc 2G, Steritalc 3G, Steritalc 4G · 8 reaction terms · 832 drug–reaction co-reports · data 2026-09-14

Drug class

Sclerosing agent

FDA label, Indications wording

Brand names

Steritalc 2G, Steritalc 3G, Steritalc 4G

openFDA label

Who reports

420 reports · 98% serious · 108 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax.

FDA label, Indications and Usage

What it is

11. DESCRIPTION STERITALC (talc) is a sclerosing agent for intrapleural administration.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 7 strongest signals

Labeled adverse reaction 1Not in label — unassessed 6

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Deformity	78	418.9 342.5–512.4ROR 514.2 · χ² 31,848 / p <1e-300	376.9 EB05 311.8 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 279.8	no trial data cached
Disability	130	330.2 286.0–381.2ROR 477.8 · χ² 42,095 / p <1e-300	312.9 EB05 270.3 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 198.7	no trial data cached
Quality of life decreased	86	321.6 266.2–388.7ROR 404.2 · χ² 27,011 / p <1e-300	298.4 EB05 249.1 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 231.6	no trial data cached
Injury	198	140.3 126.7–155.3ROR 264.5 · χ² 27,257 / p <1e-300	138.1 EB05 122.7 · IC025 +6.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 102.1	no trial data cached
Anxiety	222	38.9 35.5–42.6ROR 81.4 · χ² 8,261 / p <1e-300	38.7 EB05 34.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Emotional distress	92	37.8 31.6–45.3ROR 48.2 · χ² 3,279 / p <1e-300	37.5 EB05 31.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Lung neoplasm malignant	22	26.6 17.7–40.0ROR 28.0 · χ² 517 / p 8e-115	26.1 EB05 18.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.8 · ♀ 24% (drug 47%)	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Anxiety	222	38.9 35.5–42.6ROR 81.4 · χ² 8,261 / p <1e-300	38.7 EB05 34.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Injury	198	140.3 126.7–155.3ROR 264.5 · χ² 27,257 / p <1e-300	138.1 EB05 122.7 · IC025 +6.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 102.1	no trial data cached
Disability	130	330.2 286.0–381.2ROR 477.8 · χ² 42,095 / p <1e-300	312.9 EB05 270.3 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 198.7	no trial data cached
Emotional distress	92	37.8 31.6–45.3ROR 48.2 · χ² 3,279 / p <1e-300	37.5 EB05 31.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Quality of life decreased	86	321.6 266.2–388.7ROR 404.2 · χ² 27,011 / p <1e-300	298.4 EB05 249.1 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 231.6	no trial data cached
Deformity	78	418.9 342.5–512.4ROR 514.2 · χ² 31,848 / p <1e-300	376.9 EB05 311.8 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 279.8	no trial data cached
Lung neoplasm malignant	22	26.6 17.7–40.0ROR 28.0 · χ² 517 / p 8e-115	26.1 EB05 18.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.8 · ♀ 24% (drug 47%)	no trial data cached
Squamous cell carcinoma	4	21.2 8.0–56.2ROR 21.4 · χ² 58 / p 1e-14	15.1 EB05 4.0 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Deformity — n=78, PRR 418.9
Disability — n=130, PRR 330.2
Quality of life decreased — n=86, PRR 321.6
Anxiety — n=222, PRR 38.9
Emotional distress — n=92, PRR 37.8
Lung neoplasm malignant — n=22, PRR 26.6

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Talc?

In FDA FAERS, the most frequently co-reported reaction terms for Talc are anxiety, injury, disability, emotional distress, quality of life decreased, deformity. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Talc have an FDA boxed warning?

No. The FDA label retrieved for Talc has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Talc causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID c94e51d9-beef-4b06-e053-2a95a90a754a, effective 20250625; matched on openfda.generic_name.exact:"TALC")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 8 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.